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Near to Infrared (NIR) Light Neuroprotection in Glaucomatous Optic Neuropathy

Primary Purpose

Open Angle Glaucoma

Status

Unknown status

Phase

Early Phase 1

Locations

Chile

Study Type

Interventional

Intervention

Near to infrared light retinal stimulation

Green light stimulation

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Open Angle Glaucoma, Biophotomodulation, Near to Infrared light stimulation, Neuroprotection

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnose of Ocular Hypertension (cup to disk ratio 0,6 or less, normal Humphrey 24-2 visual field with aplanatic IOP over 21 mmHg) or Mild Glaucoma (cup to disk ratio 0,6 to 0,8, characteristic Humphrey 24-2 visual field defect PSD between 3 and 6 dB).
Visual acuity 20/40 or better

Exclusion Criteria:

Diabetic retinopathy, Multiple Sclerosis, Parkinson disease
Refractive error of 3 diopters or more

Sites / Locations

Servicio de Oftalmología Hospital Van Buren

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NIR light

Green light

Arm Description

Group of patients stimulated with near to infrared light daily stimulation

Group of patients stimulated with green light.

Outcomes

Primary Outcome Measures

Pattern electroretinogram response

Secondary Outcome Measures

OCT ganglion cell layer average thickness, Visual Field defects

Full Information

NCT ID

NCT00844389

First Posted

February 13, 2009

Last Updated

September 30, 2009

Sponsor

Universidad de Valparaiso

Collaborators

Comisión Nacional de Investigación Científica y Tecnológica

1. Study Identification

Unique Protocol Identification Number

NCT00844389

Brief Title

Near to Infrared (NIR) Light Neuroprotection in Glaucomatous Optic Neuropathy

Official Title

Near to Infrared Light Stimulation Effect on Ganglion Cell Function in Glaucomatous Optic Neuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Unknown status

Study Start Date

April 2009 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Universidad de Valparaiso

Collaborators

Comisión Nacional de Investigación Científica y Tecnológica

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to evaluate if near-to-infrared light stimulation can improve retinal ganglion cell function in glaucomatous patients.

Detailed Description

Ganglion cell dysfunction in glaucomatous optic neuropathy has been ascribed to ganglion cell electrophysiological inactivation and to apoptotic cell death. Near-to-infrared light stimulation has been used to induce mitochondrial activation and to prevent apoptotic death through mitochondrial cytochrome oxidase c stimulation. Near-to-infrared light stimulation might be useful to induce ganglion cell activation and inhibit apoptotic cell death. We propose that near-to-infrared light stimulation can be used as an adjuvant treatment combined with ocular hypotensive treatment in glaucomatous patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open Angle Glaucoma

Keywords

Open Angle Glaucoma, Biophotomodulation, Near to Infrared light stimulation, Neuroprotection

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NIR light

Arm Type

Active Comparator

Arm Description

Group of patients stimulated with near to infrared light daily stimulation

Arm Title

Green light

Arm Type

Placebo Comparator

Arm Description

Group of patients stimulated with green light.

Intervention Type

Device

Intervention Name(s)

Near to infrared light retinal stimulation

Intervention Description

Patients will be stimulated with 660 nm light frequency through a LED device. Patients will be stimulated daily for two minutes for a 6 month period.

Intervention Type

Device

Intervention Name(s)

Green light stimulation

Intervention Description

Patients will be stimulated with 530 nm LED light frequency through a LED device. Patients will be stimulated daily for two minutes for a 6 month period.

Primary Outcome Measure Information:

Title

Pattern electroretinogram response

Time Frame

Every two weeks for 4 months

Secondary Outcome Measure Information:

Title

OCT ganglion cell layer average thickness, Visual Field defects

Time Frame

Every month for four months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnose of Ocular Hypertension (cup to disk ratio 0,6 or less, normal Humphrey 24-2 visual field with aplanatic IOP over 21 mmHg) or Mild Glaucoma (cup to disk ratio 0,6 to 0,8, characteristic Humphrey 24-2 visual field defect PSD between 3 and 6 dB). Visual acuity 20/40 or better Exclusion Criteria: Diabetic retinopathy, Multiple Sclerosis, Parkinson disease Refractive error of 3 diopters or more

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tatiana E Cevo, M.D

Organizational Affiliation

Universidad de Valparaiso

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Adrian Palacios, PhD

Organizational Affiliation

Universidad de Valparaiso

Official's Role

Study Director

Facility Information:

Facility Name

Servicio de Oftalmología Hospital Van Buren

City

Valparaiso

Country

Chile

12. IPD Sharing Statement

Learn more about this trial

Near to Infrared (NIR) Light Neuroprotection in Glaucomatous Optic Neuropathy

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